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Osteosarcoma NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SINGLE TECHNOLOGY APPRAISAL (STA) for MEPACT™ (Mifamurtide) Section A&B IDM Pharma Inc. 9 Parker, Suite 100 Irvine, CA. 92618 USA November 13, 2008 Page 1 of 155 Table of Contents Table of Contents ............................................................................................. 2 Section A ......................................................................................................... 6 1 Description of technology under assessment ........................................ 6 2 Statement of the decision problem ........................................................ 9 Section B ....................................................................................................... 11 3 Executive summary ............................................................................. 11 4 Context ................................................................................................ 14 4.1 Please provide a brief overview of the disease/condition for which the technology is being used. Provide details of the treatment pathway and current treatment options at each stage. ............................................. 14 4.1.1 Osteosarcoma .................................................................................... 14 4.1.2 Osteosarcoma treatment .................................................................... 15 4.1.3 The osteosarcoma patient care pathway ............................................ 20 4.1.4 Quality of life impact of osteosarcoma ................................................ 23 4.2 What was the rationale for the development of the new technology? .. 27 4.3 What is the principal mechanism of action of the technology? ............. 28 4.4 What is the suggested place for this technology with respect to treatments currently available for managing the disease/condition? ... 29 4.5 Describe any issues relating to current clinical practice, including any variations or uncertainty about best practice. ...................................... 29 4.6 Provide details of any relevant guidelines or protocols. ....................... 29 5 Equity and equality .............................................................................. 31 5.1 Identification of equity and equalities issues ........................................ 31 5.1.1 Are there any issues relating to equity or equalities? .......................... 31 5.1.2 How has the analysis addressed these issues? ................................. 31 6 Clinical evidence ................................................................................. 32 6.1 Identification of studies ......................................................................... 32 6.2 Study selection ..................................................................................... 32 6.2.1 Complete list of RCTs ........................................................................ 34 6.2.2 Inclusion and exclusion criteria ........................................................... 34 6.2.3 List of relevant RCTs .......................................................................... 34 6.2.4 List of relevant non-randomised controlled trials ................................ 35 6.2.5 Ongoing studies ................................................................................. 35 6.3 Summary of methodology of relevant RCTs ........................................ 35 6.3.1 Methods ............................................................................................. 35 6.3.2 Participants ........................................................................................ 39 6.3.3 Patient numbers ................................................................................. 40 6.3.4 Outcomes .......................................................................................... 42 6.3.5 Statistical analysis and definition of study groups ............................... 43 6.3.6 Critical appraisal of relevant RCTs ..................................................... 46 6.4 Results of the relevant comparative RCTs ........................................... 51 November 13, 2008 Page 2 of 155 6.4.1 Demographic characteristics .............................................................. 51 6.4.2 MEPACT dosing ................................................................................ 52 6.4.3 Survival .............................................................................................. 53 6.4.4 Study events ...................................................................................... 55 6.5 Meta-analysis ....................................................................................... 56 6.6 Indirect/mixed treatment comparisons ................................................. 56 6.7 Safety ................................................................................................... 56 6.7.1 MEPACT alone .................................................................................. 56 6.7.2 MEPACT in conjunction with chemotherapy ....................................... 57 6.8 Non-RCT evidence ............................................................................... 59 6.9 Interpretation of clinical evidence ......................................................... 59 6.9.1 Provide a brief statement of the relevance of the evidence base to the decision problem. Include discussion of the relevance of the outcomes assessed in clinical trials to the clinical benefits experienced by patients in practice. ....... 59 6.9.2 Identify factors that may influence the applicability of study results to patients in routine clinical practice; for example, how the technology was used in the trial, issues relating to the conduct of the trial compared with clinical practice, or the choice of eligible patients. State any criteria that would be used in clinical practice to select suitable patients based on the evidence submitted. What proportion of the evidence base is for the dose(s) given in the Summary of Product Characteristics? .................................................................................. 59 7 Cost effectiveness ............................................................................... 61 7.1 Published cost-effectiveness evaluations ............................................. 61 7.1.1 Identification of studies ....................................................................... 61 7.1.2 Description of identified studies .......................................................... 61 7.2 De novo economic evaluation(s) .......................................................... 62 7.2.1 Technology ........................................................................................ 63 7.2.2 Patients .............................................................................................. 63 7.2.3 Comparator technology ...................................................................... 65 7.2.4 Study perspective............................................................................... 65 7.2.5 Time horizon ...................................................................................... 65 7.2.6 Framework ......................................................................................... 65 7.2.7 Clinical evidence ................................................................................ 73 7.2.8 Measurement and valuation of health effects ..................................... 75 7.2.9 Resource identification, measurement and valuation ......................... 83 7.2.10 Time preferences ............................................................................... 85 7.2.11 Sensitivity analysis ............................................................................. 86 7.2.12 Statistical analysis .............................................................................. 87 7.2.13 Validity ............................................................................................... 88 7.3 Results ................................................................................................. 88 November 13, 2008 Page 3 of 155 7.3.1 Base-case analysis ............................................................................ 88 7.3.2 Subgroup analysis .............................................................................. 88 7.3.3 Sensitivity analyses ............................................................................ 89 7.3.4 Interpretation of economic evidence ................................................... 94 8 Assessment of factors relevant to the NHS and other parties ............. 96 8.1 What is the estimated annual budget impact for the NHS in England and Wales? ......................................................................................... 96 8.2 What number of patients were assumed to be eligible? How was this figure derived? ..................................................................................... 96 8.3 What assumption was made about current treatment options and uptake of technologies? ...................................................................... 97 8.4 What assumption was made about market share? .............................. 97 8.5 What unit costs were assumed? How were these calculated? ............. 97 8.6 In addition to drug costs, consider other significant costs associated with treatment. What is the recommended treatment regimen – for example, what is the typical number of visits, and does treatment involve
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